Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

Inclusion Criteria

- Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal
verge)

- No evidence of distant spread

- No prior therapy for chemotherapy or radiation therapy for rectal cancer

- Patient considered locally advanced by MRI:

- Tumour beyond mesorectal fascia, or

- Tumour ≤ 2mm from mesorectal fascia, or

- T3 tumour < 5cm from anal verge

- For female patient of childbearing potential, neither pregnant nor breastfeeding, and
under active contraception

- No peripheral neuropathy > grade1

- ECOG PS ≤ 2

- ANC > 1,500 x 10^9/L

- Platelets > 100,000 x 10^9/L

- Creatinine < 1.5 x IULN

- Bilirubin < 1.5 IULN

- SGPT (ALT) < 2.5 IULN

- No pre-existing condition which would deter chemoradiotherapy

- No uncontrolled diarrhoea or fecal incontinence

- No significant small bowel (> 200cc or 6X6X6cm) delineated within the radiation
fields

- No other serious uncontrolled concomitant illness

- Informed consent signed

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.